Albuterol Sulfate

Product NDC
50090-6560
11-digit product format
500906560
Labeler code
50090
Product ID
50090-6560_9e4a9dac-8e00-4b2d-b3a1-2c9826e32e66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
A-S Medication Solutions
Application
ANDA074880
Marketing category
ANDA
Marketing start
1997-09-17
Substance
ALBUTEROL SULFATE
Active strength
2.5 mg/3mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
021SEF3731ALBUTEROL SULFATE51022-70-9ALBUTEROL SULFATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6560-05009065600025 POUCH in 1 CARTON (50090-6560-0) / 3 mL in 1 POUCH25 pouch2023-07-17NoNoHistorical
50090-6560-15009065600175 POUCH in 1 CARTON (50090-6560-1) / 3 mL in 1 POUCH75 pouch2023-07-24NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg*/3 mlA-S Medication Solutions2023-07-24HUMAN PRESCRIPTION DRUG LABEL3